NCT07023549

Brief Summary

The goal of this clinical study is to compare the tissue adequacy, cellularity, blood contamination, accuracy, sensitivity, specificity of the 22G Franseen needle combined with three different suction techniques (dry-suction, wet-suction, and slow-pull) in Endoscopic ultrasound-guided fine-needle biopsy for solid pancreatic lesions.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
270

participants targeted

Target at P75+ for not_applicable

Timeline
13mo left

Started Jul 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress44%
Jul 2025May 2027

First Submitted

Initial submission to the registry

June 7, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 17, 2025

Completed
14 days until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2027

Last Updated

June 17, 2025

Status Verified

May 1, 2025

Enrollment Period

1.9 years

First QC Date

June 7, 2025

Last Update Submit

June 15, 2025

Conditions

Pancreatic Diseases

Keywords

22G Franseen needlesolid pancreatic lesionaspiration techniqueEndoscopic ultrasound-guided fine-needle biopsy

Outcome Measures

Primary Outcomes (1)

  • Tissue adequacy

    Grade A, existing core tissue (defined as structurally intact tissue with a long axis length of at least 550 μm) that clearly characterizes the lesion and is sufficient for diagnosis; Grade B, the presence of core fragments that do not meet the histological criteria for structural integrity, but can still be diagnosed based on cell morphology; Grade C, no diseased tissue is found and no diagnosis can be made based on the sample.

    2 months

Secondary Outcomes (5)

  • Cellularity

    2 months

  • Blood contamination

    2 months

  • Diagnostic accuracy

    6 months

  • Diagnostic sensitivity

    6 months

  • Diagnostic specificity

    6 months

Study Arms (6)

ABC group

EXPERIMENTAL
Procedure: ABC

ACB group

EXPERIMENTAL
Procedure: ACB

BAC group

EXPERIMENTAL
Procedure: BAC

BCA group

EXPERIMENTAL
Procedure: BCA

CAB group

EXPERIMENTAL
Procedure: CAB

CBA group

EXPERIMENTAL
Procedure: CBA

Interventions

ABCPROCEDURE

Suction sampling should be conducted in the sequence of dry-suction, slow-pull and wet-suction.

ABC group
ACBPROCEDURE

Suction sampling should be conducted in the sequence of dry-suction, wet-suction and slow-pull.

ACB group
BACPROCEDURE

Suction sampling should be conducted in the sequence of slow-pull, dry-suction and wet-suction.

BAC group
BCAPROCEDURE

Suction sampling should be conducted in the sequence of slow-pull, wet-suction and dry-suction.

BCA group
CABPROCEDURE

Suction sampling should be conducted in the sequence of wet-suction, dry-suction and slow-pull.

CAB group
CBAPROCEDURE

Suction sampling should be conducted in the sequence of wet-suction, slow-pull and dry-suction.

CBA group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • （1）18-80 years old (inclusive), male and female; （2）patients with pancreatic solid mass \> 1cm detected by CT/MRI/PET-CT or EUS and requiring EUS-FNB diagnosis.
  • （3）written informed consent was obtained.

You may not qualify if:

  • contraindications to endoscopy, such as severe cardiovascular and cerebrovascular diseases;
  • bleeding coagulation dysfunction (prothrombin international normalized ratio ≥1.5, platelet count ≤ 50 000) or use of antiplatelet drugs;
  • confirmed pregnancy or possible pregnancy;
  • pathological diagnosis has been obtained by other methods;
  • refuse to participate in the study, are participating in another observational clinical trial, or have participated in another clinical trial within 60 days;
  • other situations where EUS-FNB could not be performed.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

MeSH Terms

Conditions

Pancreatic Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

  • Zhao Shen Li, M.D

    Department of Gastroenterology, Changhai Hospital, Naval Medical University (Second Military Medical University), shanghai, China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jia Yi Ma, M.D

CONTACT

+8613621819595504043536@qq.com

Kai Xuan Wang, M.D

CONTACT

wangkaixuan224007@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Gastroenterology, Changhai Hospital

Study Record Dates

First Submitted

June 7, 2025

First Posted

June 17, 2025

Study Start

July 1, 2025

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

May 31, 2027

Last Updated

June 17, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)